3.0.0
1632
2025-12-05T21:41:17Z
2025-12-05T21:41:17Z
House
H
HR
2025-02-26
119
https://www.congress.gov/bill/119th-congress/house-bill/1632
[Congressional Record Volume 171, Number 38 (Wednesday, February 26, 2025)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ROY:H.R. 1632.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 18 of the United StatesConstitution--to make all Laws which shall be necessary andproper for carrying into Execution the foregoing Powers, andall other Powers vested by this Constitution in theGovernment of the United States, or any Department or Officerthereof.[Page H880]
- hsru00
Rules Committee
House
Standing
  - Referred To
2025-02-26T15:05:05Z
- hsif00
Energy and Commerce Committee
House
Standing
  - Referred To
2025-02-26T15:05:00Z

- Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
119
3081
S
2025-10-30
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  - Identical bill
CRS
- 2025-02-26
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
IntroReferral
H11100
2
House floor actions
  - hsru00
Rules Committee
- 2025-02-26
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
IntroReferral
H11100
2
House floor actions
  - hsif00
Energy and Commerce Committee
- 2025-02-26
Introduced in House
IntroReferral
Intro-H
9
Library of Congress
- 2025-02-26
Introduced in House
IntroReferral
1000
9
Library of Congress
- R000614
Rep. Roy, Chip [R-TX-21]
Chip
Roy
R
TX
21
N
- H001052
Rep. Harris, Andy [R-MD-1]
Andy
Harris
R
MD
1
2025-02-27
False
Health
- Congressional oversight
2025-07-24T14:42:28Z
- Drug safety, medical device, and laboratory regulation
2025-07-24T14:42:28Z
Health
2025-03-18T18:49:09Z
00
2025-02-26
Introduced in House
2025-05-14T15:23:05Z
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need for the product.
Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.
The FDA may decline approval if it determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.
The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request.
Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
- Display Title
45

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
2025-03-18T04:38:23Z
- Short Title(s) as Introduced
101

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
2025-03-18T04:38:22Z
Introduced in House
IH
- Official Title as Introduced
6

To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.
2025-03-18T04:33:21Z
Introduced in House
IH
- Introduced in House
2025-02-26T05:00:00Z
  - https://www.govinfo.gov/content/pkg/BILLS-119hr1632ih/xml/BILLS-119hr1632ih.xml
2025-02-26
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
text/xml
EN
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